The U.S. Food and Drug Administration has granted Cell Therapeutics, Incorporated priority review for Zevalin® ([90Y]-ibritumomab tiuxetan) as consolidation therapy for patients with follicular B-cell non-Hodgkin’s lymphoma (NHL) who achieve a response to initial therapy. Cell Therapeutics recently submitted a supplemental biologics license application (sBLA) for Zevalin to be used in this expanded indication.
Zevalin is a radioimmunotherapeutic agent currently approved in the United States for the treatment of patients with relapsed or refractory, low-grade, or follicular B-cell NHL, including those refractory to Rituxan® (rituximab). Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, Rituxan-naive, low-grade and follicular NHL; this indication is based on studies using an endpoint of overall response rate.
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